Regulatory Affairs Manager
Posted 2 weeks ago by 1751354312
Negotiable
Outside
Remote
USA
Summary: The Regulatory Affairs Manager role is focused on overseeing regulatory affairs with a specific emphasis on Structured Product Labelling (SPL) for products in the USA market. The candidate will be responsible for reviewing and submitting SPL content, monitoring updates, and managing product registrations. Strong knowledge of labelling requirements and effective communication skills are essential for success in this position. The role is fully remote and requires a background in pharmacy.
Key Responsibilities:
- Review of SPLs content labelling
- Submission of SPLs content labelling
- Monitoring of recent updates in SPL
- Escalate, notify and resolve any issues that may impact final submission
- End to end responsibility/management of product registered in USA market
- Responsible for maintaining internal tracker for SPL submissions
Key Skills:
- B. Pharmacy
- M. Pharmacy
- Effective time management and organizational skills
- Deep understanding of quality and compliance
- Problem-solving abilities
- Effective communication skills
- Flexibility to adapt to changing environments
- Capability to handle multiple priorities
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Job Title: Regulatory Affairs Manager
Location: 100% Remote
Contract: 12+ Months
Domain- Life Sciences
Job Description
In this role Candidate should have experience in regulatory affairs while essential exposure to Structured Product Labelling (SPL) for assigned products and also need to have good knowledge of labelling requirements for USA market. In depth working knowledge of SPL review and submissions.
Responsibilities
Review of SPLs content labelling
Submission of SPLs content labelling
Monitoring of recent updates in SPL
Escalate, notify and resolve any issues that may impact final submission.
End to end responsibility/ management of product registered in USA market.
Responsible for maintaining internal tracker for SPL submissions.
Qualifications we seek in you!
Minimum Qualifications / Skills
B. Pharmacy
M. Pharmacy
Preferred Qualifications/ Skills
Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
Depending on experience level, mentor newly hired staff or lead a team of junior staff.
Flexibility in responding to changing priorities or dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.